Premarket Requirements for Nitric Oxide Delivery Systems and Gas Analyzers
This guidance document outlines requirements for premarket notification submissions for three types of devices: - Nitric Oxide Delivery Apparatus - Nitric Oxide Analyzer - Nitrogen Dioxide Analyzer These devices are used together as a system for delivering nitric oxide therapy to patients, while monitoring nitric oxide and nitrogen dioxide concentrations in the breathing circuit.
Recommended Actions
- Develop comprehensive test plan covering all performance, safety and EMC requirements
- Conduct design verification testing:
- NO delivery accuracy
- NO2 production
- Analyzer accuracy
- Environmental conditions
- EMC/electrical safety
- Endurance testing
- Prepare documentation package including:
- Device description and specifications
- Test reports and data
- Software documentation
- Risk analysis
- Labeling
- Validate compatibility with specified ventilators
- Develop training materials and installation instructions
- Implement quality system controls for:
- Design controls
- Document control
- Change management
- Device master record
- Submit 510(k) with complete documentation package demonstrating compliance with all requirements
- Maintain post-market surveillance system to monitor device performance and safety
Key Considerations
Non-clinical testing
- Testing must demonstrate accuracy and stability of NO delivery within 20% of set concentration
- Testing must verify NO2 production is less than 1.0 ppm during administration of 40 ppm NO in 60% oxygen
- Endurance testing required for 2000 hours with simulated use conditions
- Testing must verify accuracy of NO and NO2 analyzers across specified ranges
- Testing must demonstrate compatibility with specified ventilators
Human Factors
- Controls must be protected from inadvertent changes
- Controls must be clearly labeled and visible from 1 meter
- Connectors must prevent incorrect connections
- Device must minimize risk of patient strangulation from tubing/wires
Software
- Software documentation required per FDA software guidance
- Must include hazard analysis, verification and validation testing
- Software version control required
Labelling
- Must include prescription statement
- Must specify validated ventilators
- Must include installation instructions
- Must include warning about required training
- Must include specifications for accuracy and alarms
- Must identify medical gas cylinder connections
Biocompatibility
- Materials must be compatible with NO gas
- Must minimize health risks from leached substances
- Must verify material compatibility after endurance testing
Safety
- Must include battery backup power if used with ventilators having backup power
- Must include alarms for NO concentration, NO2 concentration, and power
- Must prevent catastrophic release of NO
- Must meet electrical safety requirements per IEC 601-1
- Must meet EMC requirements per specified standards
Other considerations
- Must include backup/reserve NO delivery system
- Must use gas-specific connectors with check valves
- Must operate within specs from 5-40°C and 15-95% humidity
- Surface temperatures must not exceed specified limits
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms
- IEC 601-1: Medical electrical equipment - Part 1: General requirements for safety
- IEC 801-2: Electromagnetic compatibility for industrial-process measurement and control equipment
- CISPR 11: Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics
- MIL-STD-461D: Requirements for the control of electromagnetic interference emissions and susceptibility
- ASTM F 1462-93: Standard Specification for Oxygen Analyzers
- CGA C-9-1982: Standard Color Marking of Compressed Gas Containers for Medical Use
Original guidance
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